Regulation (EU) 2026/1388 of the European Parliament and of the Council of 17 June 2026 on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 (Text with EEA relevance)
Subject matter and objectives
This Regulation aims to ensure a high level of protection of human and animal health and of the environment, in accordance with the precautionary principle, and the effective functioning of the internal market in relation to plants obtained by certain new genomic techniques, to food and feed containing, consisting of or produced from such plants, and to products, other than food and feed, containing or consisting of such plants, while enhancing innovation, sustainability and competitiveness.
This Regulation lays down specific rules for the deliberate release into the environment, for any purpose other than placing on the market, of such plants and for the placing on the market of such food and feed and other products.
Scope
This Regulation applies to:
(a)
NGT plants;
(b)
food containing, consisting of or produced from NGT plants, including food containing ingredients produced from NGT plants;
(c)
feed containing, consisting of or produced from NGT plants;
(d)
products, other than food and feed, containing or consisting of NGT plants.
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘organism’ means an organism as defined in Article 2, point (1), of Directive 2001/18/EC;
(2)
‘genetically modified organism’ or ‘GMO’ means a genetically modified organism as defined in Article 2, point (2), of Directive 2001/18/EC, excluding organisms obtained through the techniques of genetic modification listed in Annex I B to Directive 2001/18/EC;
(3)
‘deliberate release’ means deliberate release as defined in Article 2, point (3), of Directive 2001/18/EC;
(4)
‘placing on the market’ means placing on the market as defined in Article 2, point (4), of Directive 2001/18/EC;
(5)
‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002;
(6)
‘feed’ means feed as defined in Article 3, point (4), of Regulation (EC) No 178/2002;
(7)
‘plant’ means a plant as defined in Article 2, point (1), of Regulation (EU) 2016/2031 of the European Parliament and of the Council ( 24 ) ;
(8)
‘plant reproductive material’ means plants capable of, and intended for, producing entire plants;
(9)
‘NGT plant’ means a genetically modified plant obtained by targeted mutagenesis or cisgenesis, or a combination thereof, and not containing any genetic material originating from outside the gene pool for conventional breeding purposes that might have been temporarily inserted during the development of that plant;
(10)
‘targeted mutagenesis’ means mutagenesis techniques resulting in one or more modifications of the DNA sequence at targeted locations in the genome of an organism;
(11)
‘cisgenesis’ means techniques of genetic modification resulting in the insertion, into the genome of an organism, of genetic material already present in the gene pool for conventional breeding purposes;
(12)
‘gene pool for conventional breeding purposes’ means the total genetic information available in one species and in other taxonomic species with which that species can be crossed, including by using advanced techniques such as embryo rescue, induced polyploidy and bridge crosses;
(13)
‘category 1 NGT plant’ means an NGT plant that:
(a)
fulfils the criteria of equivalence to conventional plants set out in Annex I and does not include any trait listed in Annex II among the traits intended to be conveyed by the genetic modifications; or
(b)
is the progeny of NGT plants as referred to in point (a), including progeny obtained by crossing of such plants, and contains no further modifications obtained through targeted mutagenesis, cisgenesis or other techniques that would make it subject to Directive 2001/18/EC or Regulation (EC) No 1829/2003;
(14)
‘category 2 NGT plant’ means an NGT plant other than a category 1 NGT plant;
(15)
‘NGT plant for food use’ means an NGT plant that may be used as food or as a source material for the production of food;
(16)
‘NGT plant for feed use’ means an NGT plant that may be used as feed or as a source material for the production of feed;
(17)
‘produced from NGT plants’ means derived, in whole or in part, from NGT plants, but not containing or consisting of NGT plants;
(18)
‘NGT product’ means food and feed containing, consisting of or produced from NGT plants, and products, other than food and feed, containing or consisting of such plants;
(19)
‘category 1 NGT product’ means an NGT product where the NGT plant it contains, consists of or is produced from is a category 1 NGT plant;
(20)
‘category 2 NGT product’ means an NGT product where the NGT plant it contains, consists of or is produced from is a category 2 NGT plant;
(21)
‘small or medium-sized enterprise’ or ‘SME’ means an SME within the meaning of Commission Recommendation 2003/361/EC ( 25 ) ;
(22)
‘chimeric protein’ means a protein created through the joining of two or more genes or parts of genes that originally coded for separate proteins.
Deliberate release of NGT plants for any purpose other than placing on the market, and placing on the market of NGT products
Without prejudice to other requirements of Union law:
(a)
a category 1 NGT plant may be deliberately released for any purpose other than placing on the market only if the plant is:
(i)
a category 1 NGT plant as referred to in Article 3, point (13)(a), and has obtained a decision declaring that status in accordance with Article 6 or 7; or
(ii)
a category 1 NGT plant as referred to in Article 3, point (13)(b), and is the progeny of plants referred to in point (i) of this point;
(b)
a category 1 NGT product may be placed on the market only if the plant concerned fulfils at least one of the conditions laid down in point (a) of this Article;
(c)
a category 2 NGT plant may be deliberately released for any purpose other than placing on the market only if it has been granted consent in accordance with Chapter III, Section 1;
(d)
a category 2 NGT product may be placed on the market only if it has been granted consent or has been authorised in accordance with Chapter III, Section 2 or 3.
Status of category 1 NGT plants and category 1 NGT products
1. The rules which apply to GMOs in Union legislation shall not apply to category 1 NGT plants that fulfil the conditions of Article 4, point (a), or to category 1 NGT products that fulfil the conditions of Article 4, point (b).
2. For the purposes of Regulation (EU) 2018/848, the rules set out in Article 5, point (f)(iii), and Article 11 of that Regulation, including Article 11(2) and (3) thereof as regards labelling pursuant to Article 10(1) of this Regulation, shall apply to category 1 NGT plants and to products produced from or by such plants. However, the adventitious or technically unavoidable presence of category 1 NGT plants, including plant reproductive material, and products produced from or by such plants in organic production or in non-organic substances and products authorised in organic production in accordance with Article 24 of Regulation (EU) 2018/848 or in agricultural ingredients for processed organic food authorised in accordance with Article 25 of that Regulation, shall not constitute non-compliance with that Regulation.
3. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the criteria of equivalence of NGT plants to conventional plants laid down in Annex I in order to adapt those criteria to scientific and technological progress, to the extent justified by advances in scientific knowledge as regards the types and extent of genetic modification which can occur naturally or through conventional breeding.
When adopting delegated acts under this paragraph, the Commission shall publish a report to justify that, on the basis of scientific evidence, the criteria of equivalence laid down in Annex I no longer reflect what can occur naturally or through conventional breeding. The report shall include an up-to-date scientific literature review as regards the types and extent of genetic modification which can occur naturally or through conventional breeding. The report must justify that, following the intended amendment to Annex I, NGT plants meeting the equivalence criteria will remain equivalent to plants occurring naturally or obtained through conventional breeding in terms of similarity of genetic modifications and similarity of potential risk.
When preparing delegated acts under this paragraph, the Commission shall take into account any relevant new or updated scientific opinions from the European Food Safety Authority (the ‘Authority’).
Procedure for the verification of category 1 NGT plant status for requests submitted prior to the deliberate release for any purpose other than placing on the market
1. To obtain the declaration of category 1 NGT plant status referred to in Article 4, point (a)(i), of this Regulation before undertaking a deliberate release of an NGT plant for any purpose other than placing on the market, the person intending to undertake the deliberate release shall submit a request to verify whether the conditions set out in Article 3, point (13)(a), of this Regulation are met (‘verification request’) to the competent authority designated in accordance with Article 4(4) of Directive 2001/18/EC of the Member State within whose territory the release is to take place, in accordance with paragraphs 2, 3 and 4 of this Article and the delegated act adopted in accordance with Article 25, point (b), of this Regulation.
2. Where a person intends to undertake the deliberate release as referred to in paragraph 1 simultaneously in more than one Member State, that person shall submit the verification request to the competent authority of one of those Member States.
3. The verification request shall be submitted in accordance with standard data formats, where they exist, in accordance with Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:
(a)
the name and the address of the requester;
(b)
the designation and specification of the NGT plant;
(c)
a description of the traits and characteristics which have been introduced or modified;
(d)
a copy of the studies, including relevant DNA sequence information, and any other available material to demonstrate that:
(i)
the plant is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);
(ii)
the NGT plant meets the criteria set out in Annex I;
(e)
in the cases referred to in paragraph 2 of this Article, an indication of the Member States in which the requester intends to undertake the deliberate release;
(f)
an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, in accordance with Article 11.
4. The verification request shall also include a declaration that none of the traits intended to be conveyed by the genetic modifications is listed in Annex II. The declaration shall be accompanied by scientific evidence, available at the time of submission of the request, substantiating the relation between the introduced genetic modifications and the traits intended to be conveyed by those genetic modifications.
5. Together with the verification request, the requester shall submit information, to the best of its knowledge, on patents or published patent applications including one or more claims on the biological material of the NGT plant, or declare the absence of such patents or published patent applications.
6. Together with the verification request and the patent information referred to in paragraph 5, the requester may submit a written declaration of the holder of a patent identified under paragraph 5 confirming the patent holder’s willingness to license the protected subject matter under fair and reasonable conditions in all Member States where the patent holder is entitled to grant such a licence. If the requester is the patent holder, it shall submit a written declaration clarifying whether:
(a)
it is willing to license the protected subject matter under fair and reasonable conditions in all Member States where it is entitled to grant such a licence; and
(b)
it is, or intends to become, a member of relevant and appropriate licensing platforms.
7. The patent information referred to in paragraph 5 and the licence declarations referred to in paragraph 6 shall not be subject to verification and shall have only declaratory value.
8. The competent authority shall acknowledge receipt of the verification request, the patent information referred to in paragraph 5 and, where applicable, the licence declarations referred to in paragraph 6 to the requester without undue delay, stating the date of receipt, and shall make them available to the Commission and to the other Member States without undue delay.
9. If the verification request does not contain all the necessary information, or if the patent information referred to in paragraph 5 or, where the requester is the holder of a patent identified under paragraph 5, the licence declaration referred to in paragraph 6 is missing, the competent authority shall declare the verification request inadmissible within 30 working days of the date of its receipt. The competent authority shall inform the requester, the Commission and the other Member States without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
10. If the verification request is not declared inadmissible in accordance with paragraph 9 of this Article, the competent authority shall verify whether the NGT plant fulfils the conditions set out in Article 3, point (13)(a), and prepare a verification report within 30 working days of the date of receipt of that verification request. The competent authority shall make the verification report available to the Commission and to the other Member States without undue delay.
11. The Commission and the other Member States may make reasoned objections to the verification report as regards the fulfilment of the conditions set out in Article 3, point (13)(a), within 20 days of the date of receipt of that report.
12. In the absence of any reasoned objection from the Commission or a Member State, the competent authority that prepared the verification report shall adopt, within 10 working days of the expiry of the deadline referred to in paragraph 11, a decision declaring whether the NGT plant is a category 1 NGT plant. It shall transmit the decision without undue delay to the requester, to the Commission and to the other Member States.
13. Where the Commission or the Member States make reasoned objections within the deadline referred to in paragraph 11, the competent authority that prepared the verification report shall forward those reasoned objections to the Commission and to the other Member States without undue delay.
14. In the cases referred to in paragraph 13 of this Article, the Commission, after having consulted the Authority, shall prepare an implementing decision declaring whether the NGT plant is a category 1 NGT plant within 45 working days of the expiry of the deadline referred to in paragraph 11 of this Article, taking the reasoned objections received into account. That implementing decision shall be adopted in accordance with the procedure referred to in Article 28(2).
15. Where the Authority is consulted in accordance with paragraph 14 of this Article, it shall make public the verification request, relevant supporting information and any supplementary information supplied by the requester, the reasoned objections, as well as its statement delivered in the framework of the consultation, with the exception of any information to which the Member State competent authority has granted confidential treatment in accordance with Article 11.
16. The Commission shall publish a summary of the decisions referred to in paragraphs 12 and 14 in the Official Journal of the European Union .
Procedure for the verification of category 1 NGT plant status for requests submitted prior to the placing on the market of NGT products
1. Where a declaration of category 1 NGT plant status referred to in Article 4, point (a)(i), has not already been made in accordance with Article 6, to obtain such a declaration before placing on the market an NGT product, the person intending to place the product on the market shall submit a verification request to the Authority in accordance with paragraphs 2 and 3 of this Article and the delegated act adopted in accordance with Article 25, point (b).
2. The verification request shall be submitted in accordance with standard data formats, where they exist, in accordance with Article 39f of Regulation (EC) No 178/2002, and shall include, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:
(a)
the name and the address of the requester;
(b)
the designation and specification of the NGT plant;
(c)
a description of the traits and characteristics which have been introduced or modified;
(d)
a copy of the studies, including relevant DNA sequence information, and any other available material to demonstrate that:
(i)
the plant is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);
(ii)
the NGT plant meets the criteria set out in Annex I;
(e)
an identification of the parts of the verification request and any other supplementary information that the requester demands to be treated as confidential, accompanied by verifiable justification, in accordance with Article 11 of this Regulation and Article 39 of Regulation (EC) No 178/2002.
3. The verification request shall also include a declaration that none of the traits intended to be conveyed by the genetic modifications is listed in Annex II. The declaration shall be accompanied by scientific evidence, available at the time of submission of the request, substantiating the relation between the introduced genetic modifications and the traits intended to be conveyed by those genetic modifications.
4. Together with the verification request, the requester shall submit information, to the best of its knowledge, on patents or published patent applications including one or more claims on the biological material of the NGT plant, or declare the absence of such patents or published patent applications.
5. Together with the verification request and the patent information referred to in paragraph 4, the requester may submit a written declaration of the holder of a patent identified under paragraph 4 confirming the patent holder’s willingness to license the protected subject matter under fair and reasonable conditions in all Member States where the patent holder is entitled to grant such a licence. If the requester is the patent holder, it shall submit a written declaration clarifying whether:
(a)
it is willing to license the protected subject matter under fair and reasonable conditions in all Member States where it is entitled to grant such a licence; and
(b)
it is, or intends to become, a member of relevant and appropriate licensing platforms.
6. The patent information referred to in paragraph 4 and the licence declarations referred to in paragraph 5 shall not be subject to verification and shall have only declaratory value.
7. The Authority shall acknowledge receipt of the verification request, the patent information referred to in paragraph 4 of this Article and, where applicable, the licence declarations referred to in paragraph 5 of this Article to the requester without undue delay, stating the date of receipt, and shall make them available to the Commission and to the Member States without undue delay. It shall make public the verification request, relevant supporting information and any supplementary information supplied by the requester, in accordance with Article 38(1) of Regulation (EC) No 178/2002, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
8. If the verification request does not contain all the necessary information or if the patent information referred to in paragraph 4 or, where the requester is the holder of a patent identified under paragraph 4, the licence declaration referred to in paragraph 5 is missing, the Authority shall declare the verification request inadmissible within 30 working days of the date of its receipt. The Authority shall inform the requester, the Commission and the Member States without undue delay of the inadmissibility of the verification request and shall provide the reasons of its decision.
9. If the verification request is not declared inadmissible in accordance with paragraph 8 of this Article, the Authority shall deliver a statement on whether the NGT plant fulfils the conditions set out in Article 3, point (13)(a), within 30 working days of the date of receipt of that verification request. It shall make the statement available to the Commission and to the Member States. The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its statement public, after omission of any information identified as confidential in accordance with Articles 39 to 39e of Regulation (EC) No 178/2002 and Article 11 of this Regulation.
10. The Commission shall prepare an implementing decision declaring whether the NGT plant is a category 1 NGT plant within 30 working days of the date of receipt of the statement of the Authority, taking the latter into account. That implementing decision shall be adopted in accordance with the procedure referred to in Article 28(2).
The Commission shall publish a summary of that decision in the Official Journal of the European Union .
System of exchange of information between the Commission, the Authority and Member States
The Commission shall set up and maintain an electronic system for the submission of verification requests, patent information and licence declarations in accordance with Articles 6 and 7 and for the exchange of the information under this Chapter.
Database of decisions declaring category 1 NGT plant status
1. The Commission shall establish and maintain a database listing the decisions declaring the category 1 NGT plant status adopted in accordance with Article 6(12) and (14) and Article 7(10).
The database shall contain the following information:
(a)
the name and the address of the requester;
(b)
the designation and specification of the category 1 NGT plant;
(c)
a summarised description of the techniques used to obtain the genetic modifications;
(d)
a description of the traits and characteristics which have been introduced or modified;
(e)
an identification number;
(f)
where available, the statement of the Authority, as referred to in Article 6(15) and Article 7(9);
(g)
the decision referred to in Article 6(12) or (14), or Article 7(10), as applicable;
(h)
the patent information referred to in Article 6(5) and Article 7(4); and
(i)
the licence declarations referred to in Article 6(6) and Article 7(5), where applicable.
The database shall be publicly available online.
2. Should there be any change in the patent information referred to in paragraph 1, point (h), or the licence declarations referred to in paragraph 1, point (i), the requester, acting to the best of its knowledge, shall without undue delay inform the Commission of such a change. The Commission shall update the database accordingly.
Labelling of category 1 NGT plant reproductive material, including breeding material, and transparency of information
1. Plant reproductive material, including for breeding and scientific purposes, that contains or consists of category 1 NGT plants and is made available to third parties, whether in return for payment or free of charge, shall bear a label with the indication ‘NGT-1’, followed by the identification numbers of the NGT plants it has been derived from.
2. The competent authorities shall include the indication that a variety contains or consists of category 1 NGT plants, and the identification numbers of the category 1 NGT plants it has been derived from, in the catalogues of varieties referred to in Council Directive 68/193/EEC ( 26 ) , Directives 2002/53/EC and 2002/55/EC and Council Directive 2008/90/EC ( 27 ) .
3. The competent authorities shall include the indication that basic material intended for the production of forest reproductive material of the ‘tested’ category contains or consists of category 1 NGT plants, and the identification numbers of the category 1 NGT plants it has been derived from, in the national lists referred to in Council Directive 1999/105/EC ( 28 ) .
4. The indication that plant reproductive material contains or consists of category 1 NGT plants, and the identification numbers of the category 1 NGT plants it has been derived from, shall be included in any database and marketing documentation where the plant reproductive material is offered.
Confidentiality
1. The requester referred to in Article 6 may submit a request to the Member State competent authority, and the requester referred to in Article 7 may submit a request to the Authority, to treat certain parts of the information submitted under this Chapter as confidential. The confidentiality request shall be accompanied by verifiable justification in accordance with paragraphs 3 and 6 of this Article.
2. The Member State competent authority or the Authority, as appropriate, shall assess the confidentiality request referred to in paragraph 1.
3. The Member State competent authority or the Authority, as appropriate, may grant confidential treatment only with respect to the following items of information, upon verifiable justification, where the requester demonstrates that the disclosure of such information would potentially harm the requester’s interests to a significant degree:
(a)
items of information referred to in Article 39(2), points (a), (b) and (c), of Regulation (EC) No 178/2002;
(b)
DNA sequence information; and
(c)
breeding patterns and strategies.
4. Where the Member State competent authority assesses the confidentiality request, it shall, after consultation with the requester, decide which information is to be treated as confidential and shall inform the requester of its decision. Where the Authority assesses the confidentiality request, it shall apply the procedure set out in Article 39b of Regulation (EC) No 178/2002.
5. The Commission, the Authority and Member States shall take the necessary measures to ensure that confidential information notified or exchanged under this Chapter is not made public.
6. The relevant provisions of Articles 39e and 41 of Regulation (EC) No 178/2002 shall apply mutatis mutandis .
7. If the requester withdraws the verification request referred to in Article 6 or 7, the Commission, the Authority and Member States shall respect the confidentiality as granted by the Member State competent authority or the Authority in accordance with this Article. Where the verification request is withdrawn before the Member State competent authority or the Authority has decided on the corresponding confidentiality request, the Commission, the Authority and Member States shall not make public the information for which confidentiality has been requested.
Status of category 2 NGT plants and category 2 NGT products
The rules which apply to GMOs in Union legislation, in so far as they are not derogated from by this Regulation, shall apply to category 2 NGT plants and category 2 NGT products.
Notification referred to in Article 6 of Directive 2001/18/EC
As regards the deliberate release of a category 2 NGT plant for any purpose other than placing on the market, the notification referred to in Article 6(1) of Directive 2001/18/EC shall include:
(a)
the name and the address of the notifier;
(b)
a copy of the studies, including relevant DNA sequence information, and any other available material to demonstrate that the plant is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);
(c)
a technical dossier supplying the information specified in Annex III necessary to carry out the environmental risk assessment of the deliberate release of the NGT plant or combination of NGT plants, containing:
(i)
general information including information on personnel and training;
(ii)
information relating to each NGT plant;
(iii)
information relating to the conditions of release and the potential receiving environment;
(iv)
information on the interactions between each NGT plant and the environment;
(v)
a plan for monitoring in order to identify effects of each NGT plant on human health or the environment;
(vi)
where relevant, information on control, remediation methods, waste treatment and emergency response plans;
(vii)
an identification of the parts of the notification and any other supplementary information that the notifier requests to be treated as confidential, accompanied by verifiable justification, in accordance with Article 25 of Directive 2001/18/EC;
(viii)
a summary of the dossier;
(d)
an environmental risk assessment carried out in accordance with the principles and information set out in Parts 1 and 2 of Annex III and with the implementing act adopted in accordance with Article 27, first paragraph, point (a).
Notification referred to in Article 13 of Directive 2001/18/EC
1. As regards the placing on the market of category 2 NGT products for uses other than food or feed, the notification referred to in Article 13(1) of Directive 2001/18/EC shall contain, without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002:
(a)
the name and the address of the notifier and, if the notifier is not established in the Union, of its representative established in the Union;
(b)
the designation and specification of the category 2 NGT plant concerned;
(c)
scope of the notification:
(i)
cultivation; or
(ii)
other uses, to be specified in the notification;
(d)
a copy of the studies, including relevant DNA sequence information, and any other available material to demonstrate that the plant concerned is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);
(e)
the environmental risk assessment carried out in accordance with the principles and information set out in Parts 1 and 2 of Annex III and with the implementing act adopted in accordance with Article 27, first paragraph, point (a);
(f)
the conditions for the placing on the market of the product, including specific conditions of use and handling;
(g)
with reference to Article 15(4) of Directive 2001/18/EC, a proposed period for the consent, which shall not exceed 10 years;
(h)
a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan, which may be different from the proposed period for the consent; however, a monitoring plan shall not be required where the notifier duly justifies that it is not needed on the basis of the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the category 2 NGT plant concerned, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, first paragraph, point (b), of this Regulation and the guidance referred to in Article 29(1) of this Regulation;
(i)
a proposal for labelling which shall comply with the requirements laid down in point A.8 of Annex IV to Directive 2001/18/EC, Article 4(6) of Regulation (EC) No 1830/2003 and Article 24 of this Regulation;
(j)
proposed commercial names of the products and names of the category 2 NGT plants contained therein, and a proposal for a unique identifier for the category 2 NGT plant, developed in accordance with Commission Regulation (EC) No 65/2004 ( 29 ) ; after the consent, any new commercial names shall be provided to the competent authority;
(k)
a description of how the product is intended to be used; differences in use or management of that product compared to similar products not containing or consisting of genetically modified organisms shall be highlighted;
(l)
methods for sampling – including references to existing official or standardised sampling methods –, detection, identification and quantification of the category 2 NGT plant concerned; where the notifier duly justifies that it is not feasible to provide an analytical method for identification and quantification, the arrangements for complying with analytical method performance requirements shall be adapted as set out in the implementing act adopted in accordance with Article 27, first paragraph, point (c), and the guidance referred to in Article 29(2);
(m)
samples of the category 2 NGT plant concerned, control samples, and information as to the place where the reference material can be accessed;
(n)
where applicable, the information to be provided for the purpose of complying with Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity ( 30 ) ;
(o)
an identification of the parts of the notification and any other supplementary information that the notifier requests to be treated as confidential, accompanied by verifiable justification, in accordance with Article 25 of Directive 2001/18/EC;
(p)
a summary of the dossier in a standardised form.
2. The notifier shall include in the notification information on data or results from deliberate releases of the same category 2 NGT plant or the same combination of category 2 NGT plants previously or currently notified or carried out by the notifier, whether within or outside the Union.
3. The competent authority of the Member State that prepares the assessment report referred to in Article 14 of Directive 2001/18/EC shall examine the notification for compliance with paragraphs 1 and 2 of this Article.
Specific provisions on monitoring
The written consent referred to in Article 19 of Directive 2001/18/EC shall either specify monitoring requirements, as described in Article 19(3), point (f), of that Directive, or state that monitoring is not required. Article 17(2), point (b), of Directive 2001/18/EC shall not apply if monitoring is not required by the consent.
Specific provision on analytical method performance requirements
Where appropriate, the competent authority of the Member State that prepares the assessment report referred to in Article 14 of Directive 2001/18/EC may request expert assistance from the relevant national reference laboratories referred to in Article 32 of Regulation (EC) No 1829/2003 or in Article 100 of Regulation (EU) 2017/625 to assess whether the information provided by the notifier in accordance with Article 14(1), point (l), of this Regulation justifies the application of adapted arrangements for complying with analytical method performance requirements.
Labelling in accordance with Article 24
In addition to the labelling referred to in Article 19(3), point (e), of Directive 2001/18/EC, the written consent shall specify the labelling in accordance with Article 24 of this Regulation.
Duration of the validity of the consent upon renewal
1. Consent granted under Part C of Directive 2001/18/EC shall, upon the first renewal in accordance with Article 17 of that Directive, be valid for an unlimited period, unless the decision referred to in Article 17(6) or (8) or Article 18(2) of that Directive provides that the renewal is for a limited period on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the consent.
2. The second sentence of Article 17(6) and the second sentence of Article 17(8) of Directive 2001/18/EC shall not apply.
Scope
This Section shall apply to:
(a)
category 2 NGT plants for food use or for feed use;
(b)
food containing, consisting of or produced from category 2 NGT plants, including food containing ingredients produced from category 2 NGT plants (‘category 2 NGT food’);
(c)
feed containing, consisting of or produced from category 2 NGT plants (‘category 2 NGT feed’).
Specific provisions on the application for authorisation referred to in Articles 5 and 17 of Regulation (EC) No 1829/2003
1. By way of derogation from Article 5(3), point (e), and Article 17(3), point (e), of Regulation (EC) No 1829/2003, and without prejudice to any additional information that may be required in accordance with Article 32b of Regulation (EC) No 178/2002, an application for authorisation of a category 2 NGT plant for food or feed use, or category 2 NGT food or feed shall be accompanied by a copy of the studies which have been carried out, including relevant DNA sequence information and, where available, independent, peer-reviewed studies, and any other available material to demonstrate that:
(a)
the plant is an NGT plant, including information on the techniques used to obtain it as well as information that it does not contain any genetic material originating from outside the gene pool for conventional breeding purposes where such genetic material has been temporarily inserted during the development of the plant, in accordance with the information requirements laid down in the delegated act adopted in accordance with Article 25, point (a);
(b)
the food or the feed complies with the criteria referred to in Article 4(1) or Article 16(1) of Regulation (EC) No 1829/2003, respectively, based on a safety assessment of the food or feed carried out in accordance with the principles and information laid down in Parts 1 and 3 of Annex III to this Regulation and with the implementing act adopted in accordance with Article 27, first paragraph, point (a), of this Regulation.
2. By way of derogation from Article 5(3), point (i), and Article 17(3), point (i), of Regulation (EC) No 1829/2003, an application for authorisation shall be accompanied by methods for sampling – including references to existing official or standardised sampling methods –, detection, identification and quantification of the category 2 NGT plant and, where applicable, for the detection, identification and quantification of the category 2 NGT plant in the NGT food or feed.
Where the applicant duly justifies, or where the European Union Reference Laboratory (EURL) established by Article 32, first paragraph, of Regulation (EC) No 1829/2003 concludes during the procedure referred to in Article 21(4) of this Regulation, that it is not feasible to provide an analytical method for identification and quantification, the arrangements for complying with analytical method performance requirements shall be adapted as set out in the implementing act adopted in accordance with Article 27, first paragraph, point (c), of this Regulation and the guidance referred to in Article 29(2) of this Regulation.
3. By way of derogation from Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, in the case of category 2 NGT plants for food or feed use, or food or feed containing or consisting of category 2 NGT plants, the application for authorisation shall be accompanied by:
(a)
an environmental risk assessment carried out in accordance with the principles and information set out in Parts 1 and 2 of Annex III to this Regulation and with the implementing act adopted in accordance with Article 27, first paragraph, point (a), of this Regulation;
(b)
a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC, including a proposal for the duration of the monitoring plan, which may be different from the duration of the authorisation.
The monitoring plan referred to in the first subparagraph, point (b), of this paragraph shall not be required where the applicant duly justifies that it is not needed on the basis of the results of any release notified in accordance with Section 1, the findings of the environmental risk assessment, the characteristics of the category 2 NGT plant, the characteristics and scale of its expected use and the characteristics of the receiving environment, in accordance with the implementing act adopted in accordance with Article 27, first paragraph, point (b), of this Regulation and the guidance referred to in Article 29(1) of this Regulation.
4. The application for authorisation shall contain a proposal for labelling in accordance with Article 24.
Specific provisions on the opinion of the Authority
1. By way of derogation from Article 6(1) and (2) and Article 18(1) and (2) of Regulation (EC) No 1829/2003, the Authority shall deliver an opinion on the application for authorisation referred to in Article 20 of this Regulation within six months of the date of receipt of a valid application.
Where the Authority or the competent authority of the Member State carrying out the environmental risk assessment or the food or feed safety assessment pursuant to Article 6(3), points (b) and (c), and Article 18(3), points (b) and (c), of Regulation (EC) No 1829/2003 considers that additional information is necessary, the Authority, or the competent authority of the Member State through the Authority, shall ask the applicant to submit that information within a specified time limit. In that case, the six-month period shall be extended by that additional period. The extension shall not exceed six months unless it is justified by the nature of the data requested or by exceptional circumstances.
2. In addition to the tasks referred to in Article 6(3) and Article 18(3) of Regulation (EC) No 1829/2003, the Authority shall verify whether all the particulars and documents submitted by the applicant are in conformity with Article 20 of this Regulation.
3. By way of derogation from Article 6(3), point (d), and Article 18(3), point (d), of Regulation (EC) No 1829/2003, the Authority shall forward to the EURL the particulars referred to in Article 20(2) of this Regulation and in Article 5(3), point (j), and Article 17(3), point (j), of Regulation (EC) No 1829/2003.
4. The EURL shall test and validate the method of detection, identification and quantification proposed by the applicant in accordance with Article 20(2). If the applicant justifies the application of adapted arrangements for complying with analytical method performance requirements, the EURL shall carry out an assessment of whether the claimed unfeasibility is justified. That assessment shall be made public.
5. By way of derogation from Article 6(5), point (f), and Article 18(5), point (f), of Regulation (EC) No 1829/2003, in the event of an opinion in favour of granting an authorisation, the opinion shall also include:
(a)
the method, validated by the EURL, for detection, including sampling, and, where applicable, identification and quantification of the category 2 NGT plant and for detection, identification and quantification of the category 2 NGT plant in the NGT food or feed, and a justification of any adaptation of the arrangements for complying with the analytical method performance requirements in the cases referred to in Article 20(2), second subparagraph, of this Regulation;
(b)
an indication of where appropriate reference material can be accessed.
6. In addition to the proposals for labelling referred to in in Article 6(5), point (d), and Article 18(5), point (d), of Regulation (EC) No 1829/2003, the opinion shall include a proposal for labelling in accordance with Article 24 of this Regulation.
Duration of the validity of the authorisation upon renewal
By way of derogation from Article 11(1) and Article 23(1) of Regulation (EC) No 1829/2003, upon the first renewal, the authorisation shall be valid for an unlimited period, unless the Commission decides to renew the authorisation for a limited period on justified grounds based on the findings of the risk assessment carried out pursuant to this Regulation and on experience with the use, including results of monitoring, if so specified in the authorisation.
Incentives for category 2 NGT plants and category 2 NGT products containing traits relevant for sustainability
1. The incentives set out in this Article shall apply to category 2 NGT plants and category 2 NGT products where at least one of the traits of the category 2 NGT plant intended to be conveyed by the genetic modifications is contained in Part 1 of Annex IV and that plant does not have any of the traits referred to in Part 2 of that Annex.
2. The following incentives shall apply to applications for authorisation submitted in accordance with Article 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 20 of this Regulation:
(a)
by way of derogation from Article 21(1), first subparagraph, of this Regulation, the Authority shall deliver its opinion on the application within four months of the date of receipt of a valid application, unless the complexity of the product requires application of the time limit referred to in Article 21(1) of this Regulation; both time limits may be extended under the conditions set out in Article 21(1), second subparagraph of this Regulation;
(b)
where the applicant is an SME, it shall be exempted from the payment of the financial contributions to the EURL and to the European Network of GMO Laboratories (ENGL) referred to in Article 32 of Regulation (EC) No 1829/2003.
3. In addition to the pre-submission advice referred to in Article 32a of Regulation (EC) No 178/2002, pre-submission advice for the purposes of the risk assessment conducted in accordance with Annex III to this Regulation shall be provided in accordance with this paragraph prior to notifications submitted in accordance with Article 13 of Directive 2001/18/EC in conjunction with Article 14 of this Regulation and to applications submitted in accordance with Article 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 20 of this Regulation.
The staff of the Authority shall, at the request of a potential applicant or potential notifier, provide advice on the risk hypotheses that the potential applicant or potential notifier has identified to be tested in the risk assessment by providing the information under Parts 2 and 3 of Annex III to this Regulation.
That advice shall not cover the design of studies to address the risk hypotheses unless the advice concerns guidance documents developed by the Authority in which study design is addressed. However, where the potential applicant or potential notifier is an SME, it may notify the Authority of how it intends to address the risk hypotheses referred to in the second subparagraph that it has identified to be tested in the risk assessment, including the design of the studies it intends to perform in accordance with the requirements laid down in Parts 2 and 3 of Annex III. The Authority shall provide advice on the notified information, including on the design of the studies.
4. The pre-submission advice referred to in paragraph 3 shall comply with the following requirements:
(a)
it shall be without prejudice and non-committal as to any subsequent assessment of notifications or applications by the Panel on Genetically Modified Organisms of the Authority; the staff of the Authority providing the advice shall not be involved in any preparatory scientific or technical work that is directly or indirectly relevant to the application or notification that is the subject of the advice;
(b)
for potential notifications and potential applications concerning a category 2 NGT plant to be used as seeds or other plant reproductive material, the pre-submission advice shall be provided by the Authority together, or in close collaboration, with the competent authority of the Member State to which the notification or application is going to be submitted;
(c)
the Authority shall make public without delay a summary of the pre-submission advice once an application or notification has been considered valid; Article 38(1a) of Regulation (EC) No 178/2002 shall apply mutatis mutandis ;
(d)
a potential notifier or potential applicants that is an SME can request the pre-submission advice at different points in time.
5. The Authority shall verify whether the conditions set out in paragraph 1 of this Article are met. Any request for incentives shall be submitted to the Authority at the time of request of advice referred to in paragraph 3 of this Article or the application referred to in Article 5 or 17 of Regulation (EC) No 1829/2003 in conjunction with Article 20 of this Regulation, and accompanied by the following information:
(a)
the information necessary to establish that the category 2 NGT plant meets the conditions referred to in paragraph 1;
(b)
where applicable, the information necessary to demonstrate that the applicant, potential applicant or potential notifier is an SME;
(c)
for the purposes of paragraph 3, information on the aspects listed in Part 1 of Annex III as far as it can already be provided and any other relevant information.
6. Article 25 of Directive 2001/18/EC and Article 30 of Regulation (EC) No 1829/2003 shall apply to information submitted under this Article to the Authority, as appropriate.
7. The Authority shall lay down the practical arrangements to implement paragraphs 3 to 6.
8. The Commission is empowered to adopt delegated acts in accordance with Article 26 amending the lists of traits of NGT plants laid down in Annex IV in order to adapt them to scientific and technological progress or to new evidence relating to the impact on sustainability of those traits, subject to the following conditions:
(a)
the Commission shall take into account the monitoring of the impacts of this Regulation in accordance with Article 32(2);
(b)
the Commission shall conduct and make public an up-to-date scientific literature review of the impact on environmental, social and economic sustainability of the traits it intends to add to or delete from the lists in Annex IV;
(c)
where applicable, the Commission shall take into account the results of monitoring which was carried out in accordance with Article 14(1), point (h), or Article 20(3), point (b), in respect of category 2 NGT plants harbouring the traits conveyed by their genetic modifications.
Labelling of authorised category 2 NGT products
In addition to the labelling requirements referred to in Article 21 of Directive 2001/18/EC, Articles 12, 13, 24 and 25 of Regulation (EC) No 1829/2003 and Article 4(6), (7) and (8) of Regulation (EC) No 1830/2003, and without prejudice to the requirements under other Union legislation, the labelling of authorised category 2 NGT products may also mention the traits conveyed by the genetic modifications, as specified in the consent or the authorisation pursuant to Section 2 or 3 of this Chapter. Where use is made of this provision, the label shall mention all the traits of the category 2 NGT plant conveyed by the genetic modifications.
Information requirements
The Commission is empowered to adopt delegated acts in accordance with Article 26 supplementing this Regulation concerning:
(a)
the information required to demonstrate that a plant is an NGT plant;
(b)
the preparation and the presentation of the verification requests, the content of the patent information referred to in Article 6(5) and Article 7(4), the content of the licence declarations referred to in Article 6(6) and Article 7(5), the content of the verification reports and the content of the decisions referred to in Articles 6 and 7.
Exercise of the delegation
1. The power to adopt the delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt the delegated acts referred to in Article 5(3), Article 23(8) and Article 25 shall be conferred on the Commission for a period of five years from 16 July 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
3. The delegations of power referred to in Article 5(3), Article 23(8) and Article 25 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 5(3), Article 23(8) or Article 25 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Implementing acts
The Commission shall adopt implementing acts concerning:
(a)
the methodology and information requirements for the environmental risk assessment of category 2 NGT plants and the safety assessment of category 2 NGT food and feed, in accordance with the principles and factors laid down in Annex III;
(b)
the application of Articles 14 and 20, including rules concerning the preparation and the presentation of the notification or application;
(c)
adapted arrangements for complying with analytical method performance requirements referred to in Article 14(1), point (l), and Article 20(2).
Those implementing acts shall be adopted in accordance with the procedure referred to in Article 28(3).
Before adopting the implementing acts referred to in the first subparagraph, points (a) and (b), the Commission shall consult the Authority.
Committee procedure
1. The Commission shall be assisted by the committee set up by Article 58 of Regulation (EC) No 178/2002.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Guidance
1. By 17 July 2028, the Authority shall publish detailed guidance to assist requesters, notifiers and applicants in the preparation and the presentation of the verification requests, the notifications and the applications referred to in Chapters II and III and for the implementation of Annex III.
2. By 17 July 2028, the EURL, assisted by the ENGL, shall publish detailed guidance to assist the notifier or the applicant for the application of Article 14(1), point (l), and Article 20(2).
3. By 17 July 2028, the Commission shall publish, and thereafter review and update if needed, guidance for the purpose of assisting operators, in particular breeders and farmers, on matters relating to plant intellectual property. The Commission shall consult the competent intellectual property offices of the Member States when drafting the guidance. The guidance shall include information on:
(a)
plant licensing platforms;
(b)
public organisations that have the purpose of assisting plant breeders with intellectual-property-related questions;
(c)
databases allowing operators to identify the intellectual property rights which apply to a given plant;
(d)
basic information on intellectual property rights relevant to plants, including on conditions for obtaining protection, rights conferred and their limitations, as well as compulsory cross-licensing.
4. By 17 July 2028, the Commission shall publish information for operators, with particular emphasis on breeders, about the opportunities to benefit from the various programmes, financial mechanisms and policies designed to support research and development in the area of new genomic techniques.
Code of conduct
1. The Commission, in cooperation with the Member States, shall oversee the drawing-up of a code of conduct at Union level to enhance the transparency of information relating to patents on plant biological material, to facilitate breeders’ access to such material and to enhance legal certainty for breeders and farmers (‘code of conduct’).
2. The Commission shall invite the owners of patents relating to NGT plants, representatives of voluntary platforms for the licensing of patents on plant biological material, plant breeder and farmer organisations as well as other civil society organisations and other interested parties, as appropriate, to participate on a voluntary basis in the drawing-up of the code of conduct.
3. The Commission shall aim that the code of conduct include the following commitments by patent owners:
(a)
the provision of clear, comprehensive and publicly accessible information on patents and patent applications covering biological material incorporated in plant varieties placed on the market in the Union;
(b)
arrangements for the licensing of patents under fair and reasonable conditions, including through the voluntary platforms referred to in paragraph 2;
(c)
the amicable settlement of patent disputes involving breeders which are SMEs, or involving farmers in the case of unintentional minor presence of patented biological material in their fields.
4. The Commission shall aim that the code of conduct include the following commitments by voluntary platforms for the licensing of plant biological material:
(a)
cost-attractive fees for participation in the platforms to facilitate participation in the platforms by breeders which are SMEs;
(b)
standard licence agreements;
(c)
fair and impartial mechanisms for settling disagreements on licensing fees.
5. The Commission shall aim that the code of conduct set out its objectives, contain indicators to measure the achievement of those objectives, take due account of the needs and interests of all interested parties at Union level, including plant breeders and farmers, and provide a reporting framework to ensure that participants annually report to the Commission on any measures taken to implement the code of conduct and their outcomes, including aggregated information on licences granted under the arrangements referred to in paragraph 3, point (b). The Commission may provide recommendations to operators in the drawing-up of the code of conduct.
6. The Commission shall monitor the rate of participation in, and the functioning of, the code of conduct and the achievement of its aims, as referred to in paragraphs 1 to 5.
7. By 17 July 2033 and every five years thereafter, the Commission shall publish a report on the evaluation of the functioning of the code of conduct. In its evaluation, the Commission shall examine the results of the drawing-up of the code of conduct referred to in paragraphs 1 to 5 and of the monitoring referred to in paragraph 6. In this context, the Commission shall also assess if and to what extent provisions covered in the code of conduct have been infringed and if the code of conduct has ensured fair and reasonable access to patented NGT plant biological material. The report shall be accompanied, where appropriate, by legislative proposals to safeguard the good functioning of the sector, in particular access to patented NGT plant biological material for primary users, including farmers.
8. The code of conduct shall be ready by 17 January 2028.
NGT plant patent expert group and the assessment on the impact of NGT plant patenting
1. The Commission shall establish an expert group on the effect of the patenting of NGT plants (the ‘expert group’).
2. The expert group shall assist the Commission and exchange information on a regular basis as regards the assessment conducted by the Commission in accordance with paragraph 4 on the effect of patent law and the implementation practice on access to modified genetic resources, transparency of the patent landscape and innovation in the field of NGT plants. The expert group shall, in particular, assist the Commission on surveying the patent licensing practices for the breeding and marketing of NGT plants protected by a patent, ongoing patent application procedures concerning NGT plants and patent enforcement practices vis-à-vis farmers and, if available, examples of cases thereof.
3. The expert group shall be constituted in accordance with the horizontal rules on the creation and operation of Commission expert groups. Each Member State may appoint a delegation of maximum two experts to the expert group. That delegation shall have knowledge and experience in the areas covered by this Regulation and in the area of intellectual property rights, including their impact on the market. The European Patent Office and the Community Plant Variety Office may each appoint one expert to the expert group.
4. The Commission shall regularly assess the impact that the patenting of NGT plants, traits and techniques, as well as related licensing and transparency practices, have in the Union on:
(a)
innovation in plant breeding;
(b)
breeders’ access to patented plant biological material, traits and techniques, and breeders’ ability to conduct experimentation;
(c)
farmers’ access to plant reproductive material, including the price of available products and other commercially available propagating material, as well as their rights to use farm-saved seeds and propagating materials;
(d)
the risk of litigation involving farmers or breeders in situations where patented plant biological material may appear in their crops or products due to accidental presence or similarity, without intentional use of the patented plant biological material;
(e)
competition in the plant-breeding sector, in particular from the perspective of small and medium-sized breeders, while considering the potential risks of market concentration; and
(f)
transparency and legal certainty regarding patented plant biological material.
5. The first of the assessments referred to in paragraph 4 shall be conducted one year after NGT products have become available on the Union market.
6. The assessment referred to in paragraph 4 shall also include an evaluation of the necessary conditions to ensure that the Union breeding sector using new genomic techniques has a fair and reasonable access to patented plant biological material, exploring the possibility of granting access for free to such material.
7. When carrying out the assessment referred to in paragraph 4 and when considering the appropriate follow-up actions, the Commission shall take into account the findings of the expert group as well as the reporting from the Union breeding sector. To this end, the Commission shall invite the Union breeding sector to report on its experience with commercial access to patented plant biological material.
8. The assessment referred to in paragraph 4 shall be published and made accessible to the public.
9. The expert group may continue working for as long as necessary after the completion of the assessment referred to in paragraph 4.
10. If the assessment referred to in paragraph 4 reveals significant barriers to access to patented plant biological material, undue restrictions on experimentation, negative effects on breeders and farmers, increased market concentration, reduced diversity in seed supply, insufficient transparency, or other evidence that the system is not functioning smoothly, the Commission shall, where appropriate, submit legislative proposals to set up mandatory conditions or safeguards.
11. If the Commission considers that, on the basis of the assessment referred to in paragraph 4, no follow-up measures are necessary, it shall inform the European Parliament and the Council thereof and shall repeat the assessment as defined in paragraph 4 no sooner than four years and no later than six years after the publication of the first assessment.
Monitoring, reporting and evaluation
1. No sooner than three years and no later than seven years after the first decision is adopted in accordance with Article 6(12) or (14) or Article 7(10) or in accordance with Section 2 or 3 of Chapter III, whichever is the earliest, and thereafter every five years, the Commission shall forward to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the implementation of this Regulation. The report shall also address any ethical issues that have arisen with the application of this Regulation.
2. For the purposes of the reporting referred to in paragraph 1, the Commission shall, by 17 July 2028 and after consulting the competent authorities of the Member States referred to in Directive 2001/18/EC and Regulation (EC) No 1829/2003, establish a detailed programme for monitoring the impact of this Regulation, based on indicators. It shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the relevant data and other evidence.
3. No sooner than two years and no later than three years after the publication of the first report referred to in paragraph 1, the Commission shall carry out an evaluation of the implementation of this Regulation and its impact on human and animal health, the environment, consumer information, the functioning of the internal market, SMEs, the breeding sector, the organic sector, and economic, environmental and social sustainability.
The Commission’s evaluation shall also assess the impact of the application of this Regulation and, in particular, of Article 5(2) on the organic sector, including the perception thereof of organic operators and consumers.
The evaluation shall also examine whether the implementation of this Regulation creates any administrative, economic, or practical burdens for organic operators, including any effects on their ability to rely on existing compliance assurance mechanisms.
On the basis of the evaluation, the Commission shall submit, where appropriate, a legislative proposal to the European Parliament and to the Council.
4. The Commission shall present a report on the main findings of the evaluation referred to in paragraph 3 to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions.
Sustainability
1. As part of the programme for monitoring referred to in Article 32(2), the Commission and Member States shall monitor the sustainability impact of NGT plants, in particular by considering:
(a)
the positive and negative environmental, economic and social impact of the traits introduced with new genomic techniques;
(b)
the application and effects of the exclusion from category 1 status of NGT plants including traits listed in Annex II among the traits intended to be conveyed by the genetic modifications.
Specific indicators shall be established for this purpose in accordance with Article 32(2) and shall be regularly reviewed. The programme for monitoring shall collect data from multiple sources, which may include information provided during the verification procedure for category 1 NGT plants, during the notification and authorisation procedures for category 2 NGT plants and products, or during variety registration procedures, relevant databases and marketing documentation for NGT plant reproductive material, literature, and case studies focusing on traits introduced in NGT plants, as well as data originating from official controls as referred to in Article 34.
2. The Commission shall include the outcome of the work referred to in paragraph 1 of this Article in the implementation reports referred to in Article 32(1), and in the evaluation referred to in Article 32(3). The evaluation shall also assess the need for further measures intended to promote the development of NGT plants with traits contributing to environmental, economic and social sustainability.
3. The Commission and Member States may consider, where appropriate, the outcome of the work referred to in paragraph 1 in relevant strategies concerning a sustainable agrifood system and the bioeconomy, such as those aimed at supporting research, innovation and development activities.
Member State controls
Member States shall ensure that the competent authorities organise inspections and other control measures, as appropriate, to ensure compliance with this Regulation. In the event of the release of an NGT plant or the placing on the market of an NGT product that does not meet the requirements of Article 4, the Member State concerned shall ensure that necessary measures are taken to terminate the release or placing on the market, to initiate remedial action if necessary, and to inform the public, the Commission and other Member States.
Where Regulation (EU) 2017/625 applies, the official controls and other official activities shall be planned and performed in accordance with that Regulation.
References in other Union legislation
With regard to category 2 NGT plants, references in other Union legislation to Annex II or III to Directive 2001/18/EC shall be construed as references to Parts 1 and 2 of Annex III to this Regulation.
Administrative review
Any decision taken under, or failure to exercise, the powers vested in the Authority by this Regulation may be reviewed by the Commission on its own initiative or on request from a Member State or from any person directly and individually concerned.
A request to this effect shall be submitted to the Commission within two months of the date on which the Member State or person concerned became aware of the decision or failure to exercise the powers in question.
The Commission shall, within two months of the submission of the request, take a decision requiring, if appropriate, the Authority to withdraw its decision or to remedy its failure to exercise the powers.
Amendments to Regulation (EU) 2017/625
Article 23 of Regulation (EU) 2017/625 is amended as follows:
(1)
in paragraph 2, point (a)(ii) is replaced by the following:
‘(ii)
the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Article 14(1), point (h), and Article 20(3), point (b), of Regulation (EU) 2026/1388 of the European Parliament and of the Council ( *1 ) ;
( *1 ) Regulation (EU) 2026/1388 of the European Parliament and of the Council of 17 June 2026 on plants obtained by certain new genomic techniques and their products, and amending Regulation (EU) 2017/625 ( OJ L, 2026/1388, 26.6.2026, ELI: http://data.europa.eu/eli/reg/2026/1388/oj )’;"
(2)
in paragraph 3, point (b) is replaced by the following:
‘(b)
the cultivation of GMOs for food and feed production and the correct application of the plan for monitoring referred to in Article 13(2), point (e), of Directive 2001/18/EC, in Article 5(5), point (b), and Article 17(5), point (b), of Regulation (EC) No 1829/2003 and in Article 14(1), point (h), and Article 20(3), point (b), of Regulation (EU) 2026/1388;’.
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 17 July 2028. However, Articles 29, 30 and 31 shall apply from 16 July 2026.
Supplementary provisions
CRITERIA OF EQUIVALENCE OF NGT PLANTS TO CONVENTIONAL PLANTS
ANNEX ISupplementary provisions
ANNEX I
CRITERIA OF EQUIVALENCE OF NGT PLANTS TO CONVENTIONAL PLANTS
An NGT plant is considered equivalent to conventional plants if the genetic modifications introduced by the new genomic techniques meet the following conditions:
(1)
In the case of plants obtained by targeted mutagenesis, the genetic modifications are the following:
(a)
substitution or insertion of no more than 20 nucleotides;
(b)
deletion of any number of nucleotides.
The number of those genetic modifications does not exceed a limit of three for each protein-coding sequence, taking into account that genetic modifications in introns and regulatory sequences are not subject to that limit.
(2)
In the case of plants obtained by cisgenesis, the genetic modifications:
(a)
consist of one or more of the following types:
(i)
insertion of continuous DNA sequences existing in the gene pool for conventional breeding purposes;
(ii)
substitution of endogenous DNA sequences with continuous DNA sequences existing in the gene pool for conventional breeding purposes;
(iii)
inversion or translocation of continuous endogenous DNA sequences; and
(b)
fulfil one or both of the following conditions:
(i)
they result in a combination of DNA sequences that occurs in the gene pool for conventional breeding purposes;
(ii)
they do not lead to interruptions of endogenous genes, including interruptions that create chimeric proteins.
(3)
The number of genetic modifications referred to in points 1 and 2 in any combination does not exceed 20 per monoploid genome.
TRAITS REFERRED TO IN ARTICLE 3, POINT (13)(a), THAT EXCLUDE NGT PLANTS FROM CATEGORY 1 STATUS
ANNEX IISupplementary provisions
ANNEX II
TRAITS REFERRED TO IN ARTICLE 3, POINT (13)(a), THAT EXCLUDE NGT PLANTS FROM CATEGORY 1 STATUS
(1)
Tolerance to herbicides
(2)
Production of a known insecticidal substance
RISK ASSESSMENT OF CATEGORY 2 NGT PLANTS AND CATEGORY 2 NGT FOOD AND FEED
ANNEX IIISupplementary provisions
ANNEX III
RISK ASSESSMENT OF CATEGORY 2 NGT PLANTS AND CATEGORY 2 NGT FOOD AND FEED
The objective of a risk assessment is to identify and evaluate, on a case-by-case basis, potential adverse effects of the category 2 NGT plant or category 2 NGT food or feed, either direct or indirect, immediate or delayed, on human, animal health and the environment, including on biodiversity.
Part 1 of this Annex describes the general principles to be followed to perform the environmental risk assessment of category 2 NGT plants referred to in Article 13, points (c) and (d), Article 14(1), point (e), and Article 20(3), point (a), and the safety assessment of category 2 NGT food and feed referred to in Article 20(1), point (b). Part 2 describes specific information for the environmental risk assessment of category 2 NGT plants. Part 3 describes specific information for the safety assessment of category 2 NGT food and feed.
PART 1
General principles and information
The environmental risk assessment shall be carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC.
The type and amount of information necessary for the environmental risk assessment of category 2 NGT plants laid down in Annex III to Directive 2001/18/EC and for the food and feed safety assessment of category 2 NGT food and feed shall be adapted on a case-by-case basis. Factors to be considered include:
(a)
the characteristics of the category 2 NGT plant, in particular the traits introduced, the function of the modified or inserted genomic sequences and the function of any gene disrupted by the insertion of a cisgene or parts thereof;
(b)
prior experience with the consumption of plants of the same species or of a species exhibiting similar traits or in which similar genomic sequences have been modified, inserted or disrupted, or their products;
(c)
prior experience with the cultivation of plants of the same species or of a species exhibiting similar traits or in which similar genomic sequences have been modified, inserted or disrupted;
(d)
the scale and conditions of the release;
(e)
the intended conditions of use of the category 2 NGT plant concerned;
(f)
the potential receiving environment.
The environmental risk assessment of category 2 NGT plants and the food and feed safety assessment of category 2 NGT food and feed shall consist of the following:
(a)
hazard identification and characterisation;
(b)
exposure characterisation;
(c)
risk characterisation;
(d)
risk management strategies, where applicable;
(e)
overall risk evaluation and conclusion.
The following information shall always be required:
(A)
Hazard identification and hazard characterisation
Information relating to the recipient plant or, where appropriate, to the parental plants and information relating to molecular characterisation shall be provided by collating available data from scientific literature or from other sources or by generating scientific data, where necessary by performing appropriate experimental or bioinformatic studies.
Information on hazard identification and hazard characterisation specified under Parts 2 and 3 shall be required only if it is necessary for addressing the risk hypothesis for the category 2 NGT plant or category 2 NGT food or feed.
(B)
Exposure characterisation
Information shall be provided on the likelihood of each identified potential adverse effect. This shall be evaluated taking into consideration, as relevant, the characteristics of the receiving environment, the scale and conditions of release, the intended function, the dietary role, the expected level of use of the food and feed in the Union and the scope of the application for authorisation.
(C)
Risk characterisation
The applicant shall base the risk characterisation of category 2 NGT plants or category 2 NGT food or feed on information from hazard identification, hazard characterisation and exposure assessment. The risk shall be characterised by combining, for each potential adverse effect, the magnitude with the likelihood of that adverse effect occurring to provide a quantitative or semi-quantitative estimation of the risk. Where relevant, the uncertainty for each identified risk shall be described and, where possible, expressed in quantitative terms.
PART 2
Specific information for the environmental risk assessment of category 2 NGT plants concerning hazard identification and hazard characterisation
(1)
Analysis of agronomic, phenotypic and compositional characteristics
(2)
Persistence and invasiveness, including any selective advantage and disadvantage
(3)
Potential gene transfer
(4)
Interactions of the category 2 NGT plant with target organisms
(5)
Interactions of the category 2 NGT plant with non-target organisms
(6)
Impacts of the specific cultivation, management and harvesting techniques
(7)
Effects on biogeochemical processes
(8)
Effects on human and animal health
PART 3
Specific information for the safety assessment of category 2 NGT food and feed concerning hazard identification and hazard characterisation
(1)
Analysis of agronomic, phenotypic and compositional characteristics
(2)
Toxicology
(3)
Allergenicity
(4)
Nutritional assessment
TRAITS REFERRED TO IN ARTICLE 23
ANNEX IVSupplementary provisions
ANNEX IV
TRAITS REFERRED TO IN ARTICLE 23
PART 1
Traits justifying the incentives referred to in Article 23:
(1)
yield, including yield stability and yield under low-input conditions;
(2)
tolerance or resistance to biotic stresses, including plant diseases caused by nematodes, fungi, bacteria, viruses and other pests;
(3)
tolerance or resistance to abiotic stresses, including those created or exacerbated by climate change;
(4)
more efficient use of resources, such as water and nutrients;
(5)
reduced need for external inputs, such as plant protection products and fertilisers;
(6)
characteristics that enhance the sustainability of storage, processing and distribution;
(7)
improved quality or nutritional characteristics;
(8)
bioremediation.
PART 2
Traits excluding the application of the incentives referred to in Article 23:
tolerance to herbicides.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
